Table 2 Study characteristics of all studies included in the systematic review^†

Baleeiro and Mull [32]³¹

Study Design:

Case series

(Abstract only)

Enrollment Dates:

2007–2010

Location: United States

Funding:

NR

Possible Conflicts of Interest:

NR

N of COPD patients = 17 patients

Method of Recruitment:

Clinic patients

Sex:

NR

Mean Age (SD):

NR

Smoking History:

Most cases tobacco related

Comorbidities:

Bronchiecstasis, CVID

Treatment Group:

Treatment Administration:

IVIG or SCIG

Dosage:

NR

Duration of intervention:

NR

PFT, Ig, and other parameters of interest were not reported

PFT Results:

NR

Ig Levels:

NR

Other Parameters:

NR

No control group

Cowan et al. [33]²⁹

Study Design: Retrospective Case series

Enrollment Dates:

2008 – 2014

Location: Canada

Funding:

None

Possible Conflicts of Interest: None

N of COPD patients = 14 patients (out of 33 subjects with COPD that had Ig treatment). (Among exclusions: 11 not firm diagnosis of COPD, 5 had incomplete records, 3 excluded because < 3 months treatment due to intolerance of therapy)

Method of Recruitment:

Other: Review of medical records

Sex:

6 (43%) males, 8 (57%) females

Mean Age (SD):

67.1 ± 12.1

Smoking History: NR

Comorbidities:

8 cases bronchiectasis

7 cases with asthma

5 cases obese (BMI > 30)

2 CAD

1 diabetes

1 monoclonal gammopathy

No control group

Treatment Administration:

6 on IVIG, 7 on SCIG, 1 switched from IVIG to SCIG due to intolerance

Dosage:

0.5 ± 0.3 g/kg/month

Duration of intervention:

363.1 ± 6.9 days

FEV1, L/sec:

FEV1, %:

FEV1/FVC, %:

N patients with severe COPD

Mean serum IgG, g/L

Mean serum IgG < 7 g/L

Mean serum IgG < 5 g/L

Other Parameters:

Mean rate of moderate/severe AECOPD per year:

Mean rate of moderate AECOPD per year:

Mean rate of severe AECOPD per year:

PFT Results:

1.2 ± 0.8

46.3 ± 18.6

43.4 ± 15.3

8

Ig Levels:

6.2 ± 2.2

9 (hypogammaglobulinemia)

5 out of the 9 (significant hypogammaglobulinemia

Other Parameters:

4.65

3.8 (53 total exacerbations)

0.86 (12 total hospitalizations)

12 hospital admissions occurred in seven of fourteen cases

No control group

Cowan et al. [35]³²

Study Design:

RCT

Enrollment Dates:

September 2016 (inpatients) and March 2018 (outpatients)

-Nov 2018

Location: Canada

Funding:

The Ottawa Hospital Academic Medical Organization

Innovative Fund, CSL Behring, and Grifols, with JC receiving grants and/or personal fees from the mentioned organizations – funders not involved in study design, conduct, analysis or interpretation

(444 assessed—failed inclusion criteria (159), refused research (114), failed exclusion criteria (75) failed both inclusion and exclusion criteria (21) died while admitted (5)

Treatment Group:

N of COPD patients = 35

Method of Recruitment: Inpatients and clinic patients

Sex: 20 males:15 females

Mean Age (SD): 66.7 ± 7.4 years

Smoking History: Pack years = 56.8 ± 27.5

Comorbidities:

- Hypertension = 57%

- Coronary artery disease = 26%

- Congestive heart failure = 11%

- Cardiomyopathy = 8%

Control Group:

N of COPD patients = 35

Method of Recruitment: Inpatients and clinic patients

Sex: 13 male:22 female

Mean Age (SD): 68.7 ± 8.7 years

Smoking History: Pack years = 51.3 ± 29.8

Comorbidities:—Hypertension = 57%

- Coronary artery disease = 43%

- Congestive heart failure = 3%

- Cardiomyopathy = 8%

Treatment Group:

Received IVIG (10% solution) q4 ± 1 weeks for 48 weeks

Dose: 0.8 g/kg for hospitalized patients with hypogammaglobulinemia, and 0.5 g/kg for all others

Control Group:

Received IV Normal Saline (NS) q4 ± 1 weeks for 48 weeks

Dose: same volume with what they would need if received IVIG

In both cases: 1st dose in hospital for inpatients—all other doses at clinical investigation unit

FEV1, L (%):

FEV1/FVC, %:

IgG, g/L:

IgM, g/L:

IgA, g/L:

IgE, mg/L

Other Parameters:

Total number of AECOPD, number/year:

Moderate AECOPD (managed as outpatient), number/year:

Moderate AECOPD (ED visit), number/year:

Severe AECOPD (hospitalization), number/year:

PFT Results:

0.90 ± 0.39(34 ± 13)

42 ± 12

Ig Levels:

8.94 ± 2.83

0.85 ± 0.76

2.69 ± 1.15

0.96 ± 1.52

Other Parameters:

2.7 ± 1.3

1.37 ± 1.44

0.34 ± 0.68

1.1 ± 0.8

PFT Results:

0.87 ± 0.4(35 ± 14)

43 ± 16

Ig Levels:

7.34 ± 1.64

0.79 ± 0.56

2.17 ± 1.27

0.35 ± 0.57

Other Parameters:

2.5 ± 1.3

0.86 ± 1.04

0.26 ± 0.56

1.4 ± 0.81

McCullagh et al. [34]³⁰

Study Design: Case series

Enrollment Dates:

January 2012 (January 2010 for the retrospective chart review patients)

-Dec 2014

Location: United States

Funding:

None

Possible Conflicts of Interest:

None

N of COPD patients = 7 patients are included in the case series and retrospective chart review

Therapeutic effect: 7 on IVIG (although the immune diagnosis was associated with the chosen therapy) (3 out of 7 of these patients were also on prophylactic antibiotics

Treatment Group:

N of COPD patients = IVIG (7)

Method of Recruitment:

Other: Clinic patients and Retrospective chart review

Sex:

NR

Mean Age (SD):

NR

Smoking History:

pack years, median (Range): 54 (30–75)

Comorbidities:

Total

- All with CVID

Treatment Group:

Treatment Administration:

IVIG OR SCIG for patients with CVID

Dosage:

IVIG was administered every 3 or 4 weeks, and SCIG was administered every 1 or 2 weeks

The total dose of IVIG or SCIG ranged from 300 to 600 mg/KG/4-week period

Duration of intervention:

- 1 year

FVC (Range)

FEV1 (Range)

FEV1/FVC (Range)

IgA, g/L (Range)

IgG, g/L (Range)

IgM, g/L (Range)

Other Parameters:

PFT Results:

64.3 (59–68) (n = 3)

41.8 (28–60) (n = 4)

42.3 (30–62) (n = 4)

Ig Levels:

0.793 (0.04–2.26)

3.556 (1.11–7.64)

0.359 (0.05–0.63)

Other Parameters:

NR

No control group